Nanjing BioPoint has recently achieved ISO13485 accreditation. The certificate has been issued by the NSF International Strategic Registration in the USA.
ISO 13485 is specifically designed for the medical device industry. It covers all aspects of the quality management system including design and development, production, installation and servicing of medical devices and related services.
Achieving ISO13485 accreditation is an important milestone for the Nanjing BioPoint. It reflects the quality culture of the company. The ISO accreditation is the precursor to other product accreditations (such as CE mark, or WHO prequalification) which will be the quality testament of Nanjing BioPoint’s innovative POCT product in the international market.